生技醫藥產業為一具有高成本及高風險特性的產業,由研發、生產技術、製程設備、潔淨廠房到各項支援系統之建置,皆須符合現行優良藥品製造規範(CGMP)之標準,其中支援系統之穩定度,是影響生產品質最關鍵之主要因素。 生技藥廠的支援系統包含廠房建築、潔淨空調系統、製程用水系統、製程氣體、潔淨蒸氣等。本研究將偏差頻率最高之潔淨空調系統,利用故障樹分析法(Fault Tree Analysis,FTA)建立一嚴重度矩陣,以作為故障元件改善之先後順序。再導入失效模式及效應之關鍵性分析手法(Failure Mode and Effective Criticality Analysis,FMECA),並參考風險優先指數(Risk Priority Number,RPN),對影響較大之高風險因子提出因應策略。 研究結論顯示執行關鍵性備品庫存以降低維護停機時間之策略,不僅對提升潔淨空調系統之穩定度有顯著成效外,更可作為其它支援系統品質改善之運用。
The bio-pharmaceutical industry is of high-cost and high-risk. Its R&D activities, production technology, process equipment, clean room and the supporting systems are all required to comply with the standards of Current Good Manufacturing Practice (CGMP). Among them, the stability of support systems is the most critical factor which affects the production quality. Bio-pharmaceutical support system consists of architecture, clean room HVAC system, pharmaceutical water system, pharmaceutical gas system and clean steam system. This research focused on the clean room HVAC systems, which had the highest frequency of deviation in the clean room supporting system. Fault Tree Analysis (FTA) was utilized to create a criticality matrix to proceed the failed components for improvement. Then, the Failure Mode and Effective Criticality Analysis (FMECA) was applied with Risk Priority Number (RPN) as a reference to provide strategy of high risk in the stability of HVAC systems. The result of this research indicates that implementation of the critical spare parts inventory strategies to reduce maintenance downtime not only enhance the stability of clean room HVAC system, but also benefit the quality improvement for other supporting systems.